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[18F]FMISO PET/CT After Transcatheter Arterial Embolization in Imaging Tumors in Patients With Liver Cancer

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ClinicalTrials.gov Identifier: NCT02695628
Recruitment Status : Recruiting
First Posted : March 1, 2016
Last Update Posted : March 7, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sanjiv Sam Gambhir, Stanford University

Brief Summary:
This clinical trial studies how well 18F-fluoromisonidazole ([18F]FMISO) positron emission tomography (PET)/computed tomography (CT) works after transcatheter arterial embolization in imaging tumors in patients with liver cancer. Transcatheter arterial embolization blocks blood flow to tumor cells by inserting tiny foreign particles into an artery near the tumor. [18F]FMISO is a type of radioimaging agent that binds to large molecules in tumor cells that have a low level of oxygen, and the radiation given off by [18F]FMISO is picked up by a PET scan and this may help researchers learn whether changes occur in the tumors after treatment, which can help decide how well the treatment worked earlier than is currently possible

Condition or disease Intervention/treatment Phase
Adult Liver Carcinoma Liver Cirrhosis Drug: 18F-Fluoromisonidazole Procedure: Arterial Embolization Diagnostic Test: Computed Tomography Diagnostic Test: Positron Emission Tomography Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine the variability of 18F FMISO uptake in hepatocellular carcinoma (HCC) tumors compared to normal liver after transcatheter arterial embolization by determining the difference in the mean of the maximum standardized uptake value (SUVmax) and tumor-to-liver ratio (TLR) of a region of normal liver and of up to 5 index tumors.

SECONDARY OBJECTIVES:

I. Determine if areas of tumor recurrence as determined by CT or magnetic resonance imaging (MRI) within a 6 month period after transcatheter arterial embolization show evidence of increased 18F FMISO labeling on the initial post treatment 18F FMISO PET/CT.

II. Determine the variability in SUVmax and TLR of untreated (non embolized) HCC lesions compared to normal liver by determining the difference in the mean of the SUVmax and TLR of normal liver and tumor.

III. Determine any toxicities related to [18F]FMISO use for PET/CT.

OUTLINE:

Patients undergo transcatheter arterial embolization. Patients also receive 18F-fluoromisonidazole intravenously (IV) and undergo PET/CT scans within 4 weeks prior to embolization treatment and in the 20 hours following completion of treatment.

After completion of treatment, patients are followed up at 2 and 3 months.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Treatment-Induced Tissue Hypoxia After Transcatheter Arterial Embolization of Hepatocellular Carcinoma: A Feasibility Study With [18F]FMISO PET/CT
Actual Study Start Date : September 13, 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diagnostic (18F-fluoromisonidazole, PET/CT, embolization)
Patients undergo transcatheter arterial embolization. Patients also receive 18F-fluoromisonidazole IV and undergo PET/CT scans 4 weeks prior to embolization treatment and in the 20 hours following completion of treatment.
Drug: 18F-Fluoromisonidazole
Undergo [18F] FMISO PET/CT
Other Names:
  • 18F-MISO
  • 18F-Misonidazole
  • FMISO

Procedure: Arterial Embolization
Undergo transcatheter arterial embolization
Other Names:
  • TAE
  • Transarterial Embolization

Diagnostic Test: Computed Tomography
Undergo [18F] FMISO PET/CT
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT SCAN
  • tomography

Diagnostic Test: Positron Emission Tomography
Undergo [18F] FMISO PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET SCAN
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging




Primary Outcome Measures :
  1. Change in SUVmax and TLR of tumors [ Time Frame: Within 4 hours prior to embolization treatment up to 20 hours following embolization ]
    TLR of SUVmax will be calculated for all imaged tumors and analyzed on the logarithmic scale. A variance components model (linear mixed effects with a random intercept for subject effect) will be fitted to the TLR; in such a model the antilog of the overall intercept can be interpreted as an overall TLR averaged across tumors and subjects. Up to 5 tumors per subject will be obtained. The between subject and within subject variance components will be used to plan further studies. The overall TLR will be reported with a P value obtained from the variance components model. A P value less than 0.0


Secondary Outcome Measures :
  1. Comparison of SUVmax and TLR of tumors with recurrence to tumors without recurrence [ Time Frame: Up to 6 months ]
    Logistic regression analysis will be performed on the independent variables, SUVmax and TLR, and the dependent variable, recurrence of tumor. An odds ratio and 95% confidence interval will be obtained.

  2. Incidence of unanticipated toxicities related to 18F-fluoromisonidazole use over a 10 half-life period beginning from injection according to the Common Terminology Criteria for Adverse Events version 4 [ Time Frame: 18 hours following injection ]
    Toxicity rates will be calculated and reported as a proportion of number of complications/number of total treatments with a corresponding 95% confidence interval.

  3. Measurement of SUVmax and TLR of untreated HCC tumor compared to normal liver, defined as any tumor that has not undergone any locoregional or systemic treatment within 3 months [ Time Frame: Up to 3 months ]
    TLR of SUVmax will be calculated for all imaged tumors and analyzed on the logarithmic scale. A variance component model will be fitted to the TLR. The overall TLR will be reported with a P value obtained from the variance components model. A P value less than 0.05 will be considered significant.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Histopathologic or imaging and clinical features of tumor(s) diagnostic for hepatocellular carcinoma with at least one tumor >= 1.5 cm; imaging features diagnostic for hepatocellular carcinoma will be defined as Liver Imaging Reporting and Data System (LIRADS) 4 or greater
  • Total bilirubin < 3.0
  • Child Pugh A or B
  • Tumor amenable to transcatheter arterial embolization
  • Able to provide informed consent

Exclusion Criteria:

  • Uncontrolled large ascites
  • Main or segmental portal vein thrombosis
  • Locoregional treatment of hepatocellular carcinoma within the prior 3 months or chemotherapy within the previous 3 months
  • Inability or contraindication to undergo transcatheter arterial embolization
  • Inability to lay flat for at least 2 consecutive hours
  • Severe acute illness
  • Uncontrolled chronic illness such as hypertension, diabetes, or heart failure
  • Contraindication to CT or MRI contrast
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02695628


Locations
United States, California
VA Palo Alto Healthcare System Recruiting
Palo Alto, California, United States, 94304
Contact: Rajesh Shah    650-723-0728      
Principal Investigator: Rajesh Shah         
Sponsors and Collaborators
Sanjiv Sam Gambhir
National Cancer Institute (NCI)
Investigators
Principal Investigator: Rajesh Shah Stanford Cancer Institute

Responsible Party: Sanjiv Sam Gambhir, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT02695628     History of Changes
Other Study ID Numbers: HEP0055
NCI-2016-00041 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
HEP0055 ( Other Identifier: OnCore )
P30CA124435 ( U.S. NIH Grant/Contract )
IRB-29768 ( Other Identifier: Stanford IRB )
First Posted: March 1, 2016    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma
Liver Cirrhosis
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Diseases
Digestive System Diseases
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Misonidazole
Antineoplastic Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents